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Regulatory Information Management: Making the Business Case for RIM Transformation

Sep 18, 2017 | Pat Shafer

Patterson Shafer, Life Sciences Specialist Leader, Deloitte Consulting LLP

Regulatory Affairs teams can be instrumental in speeding time to market through innovative registration strategies as well as effective submissions development. Regulatory also plays a key role in maintaining patient access to products and optimizing profitability through effective lifecycle management. The business case for leading-class regulatory capabilities should therefore be focused on maximizing revenue and minimizing compliance and quality costs, rather than simply focusing on process efficiency.

Value reflects the balance between costs and benefits. Investment in an effective RIM solution involves not only the RIM technology, but process, organizational change, and data management elements. However, investing in the regulatory function, if made appropriately, could return substantial benefits in cost avoidance and improved financial performance.

Previous challenges defining the business case for RIM are due in part to how the scope of change radically effects the financial impact. Any single RIM capability will likely have a proportionally smaller impact if changed independently rather than as part of a broader initiative. Due to the complexity of regulatory processes, particularly in multi-national companies, taking a unified approach will likely deliver returns far greater than the sum of smaller, isolated initiatives. Below are a few of the potential benefits from a unified approach to RIM:

  • Faster time to approval – A unified RIM solution connects planning to execution, allowing real-time process monitoring. Teams can quickly spot constraints and take corrective action. Adopting a common platform also drives consistency and reduces wasted efforts. Valuing the time saved can be measured in thousands of dollars in cost efficiencies or millions of dollars in revenue enhancement.
  • Optimize profitability and access to drug products – During lifecycle maintenance, integrating regulatory intelligence into the change control and variation management process, allows companies to manage change efficiently and reduces the risk of change-related recalls. One Top 20 company estimated wasting 75,000 hours per year on manual data entry and rework due to inefficient change control and variation management processes.
  • Improved Health Authority (HA) interactions– Higher quality submissions translates to a more efficient review process for authorities, and builds credibility. In this era of risk-based oversight, credibility translates to speed and potentially a reduced regulatory burden.
  • Compliant product release – Integrated change control and variation management processes and connection to ERP systems can greatly reduce the likelihood of releasing updated products into a market before HA approval of the variation. Recalls associated with label-related changes alone cost the industry hundreds of millions of dollars per year.
  • Talent retention – Companies report that employee turnover on regulatory teams is linked to the stress of the filing, and increases greatly if team members consider processes to be inefficient or wasteful. Being able to perform one’s job efficiently and the perception of being part of a high-performing organization contributes to employee satisfaction and retention.

    • When making the business case for RIM transformation, companies should plan, and budget for, non-technology activities such as process re-engineering and data governance initiatives. It has been said that “culture trumps strategy;” as such, changing attitudes and behaviors is no simple effort. Organizational Change Management should be integrated in all design, piloting, and implementation efforts. Investing in communications, training, and ongoing support can help ensure successful adoption and sustainment of the changes associated with implementing RIM.

    To learn more, read our latest whitepaper on the value of a holistic RIM capability.

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